title: Weight change upon once-daily initiation of insulin detemir with or without dietary intervention in overweight or obese insulin-naïve individuals with type 2 diabetes: results from the DIET trial.
abstract: OBJECTIVE
  Weight gain upon insulin initiation is opposite to clinical goals in diabetes management. This trial aimed to determine the impact of modest dietary intervention on weight change and examine weight change in baseline body mass index strata when initiating once-daily insulin detemir (IDet) in overweight or obese insulin-naïve individuals with type 2 diabetes (T2D).
  
  
  METHODS
  DIET (Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes) was a 26-week, randomized, treat-to-target, stratified, controlled, open-label, multinational trial. Subjects were randomized 1 : 1 to either the IDet group, which received basic dietary and physical exercise advice at baseline, or the Diet+IDet group, which had additional dietary consultations with a certified dietician (three face-to-face meetings, three phone contacts).
  
  
  RESULTS
  Mean estimated change in body weight from baseline ± standard error (SE) was -1.05 ± 0.23 kg for Diet+IDet and -0.56 ± 0.23 kg for IDet alone. Estimated mean difference was 0.49 kg (95% confidence interval: -0.15; 1.13, p = 0.132). Glycaemic control, measured by haemoglobin A1c (HbA1c) and fasting plasma glucose, improved similarly in both groups. Both groups reported variable reductions in caloric intake and overall physical activity levels. No difference in hypoglycaemia rates between groups was observed.
  
  
  CONCLUSIONS
  This study suggests that a modest dietary intervention plus basic lifestyle advice, compared with basic lifestyle advice alone, resulted in similar weight change, efficacy, safety and tolerability when initiating IDet once daily in overweight or obese insulin-naïve individuals with T2D.
authors.affiliation: Tennessee Valley Healthcare System and Vanderbilt University School of Medicine, Vanderbilt University, Nashville, TN, USA.
authors.forename: K
authors.initials: K
authors.lastname: Niswender
authors.forename: M
authors.initials: M
authors.lastname: Piletic
authors.forename: H
authors.initials: H
authors.lastname: Andersen
authors.forename: L
authors.initials: L
authors.lastname: Conradsen Hiort
authors.forename: P
authors.initials: P
authors.lastname: Hollander
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy* / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D037001:Directive Counseling; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009765:Obesity / Q000150:complications*; D040242:Risk Reduction Behavior; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human
keywords: HbA1c; dietary intervention; once-daily insulin detemir; type 2 diabetes; weight